A European based international oncology biotech company asked us to develop the business case for launch indications in the US and EU-5 for a novel oncology therapy in Phase I/II. They also needed to prioritise and value their follow-on clinical development indications.
We kicked-off with a workshop to capture existing thinking and identify gaps and questions. We then went back to our desks to source secondary research to develop a thorough overview of the market and competitor landscape. We built on this ground work with qualitative research with Therapeutic Area Experts and payers discussing more in detail the merits of proposed TPP, trial design and place in therapy. We included regional Payer Advisory Boards which the client enjoyed participating as they provided a first-hand insight into Payers’ issues and needs.
Ultimately, we delivered clear and quantified commercial recommendations including:
We validated the TPP by confirming that the initial indications were the right ones to prioritise. We also identified the need to consider additional indications We identified reimbursement models likely to be acceptable to payers to inform the client’s pricing and reimbursement strategy and expectations We developed a detailed financial forecast including peak sales, cost assumptions and NPV model development We gave clear direction on likely pricing and identified the potential to command an enhanced price with refined positioning and by providing more payer relevant clinical data from more targeted trials We exposed issues with the planned trial design and made recommendations to refine it to be more aligned with both payer and physician needs
As a result of our work, the client developed a complete clinical development plan including re-evaluating trials’ primary and secondary endpoints. They added an approach for demonstrating payer value and framing the commercial case including indication-specific Quality of Life questionnaires and further research on how to link study data with patient relevant outcomes. A few years later, we were retained to conduct follow-up research and analysis informing a commercial forecast update following very positive trial outcomes.
“groupH didn’t just deliver their findings, they also facilitated the intense internal discussions which led to a change in the registration study endpoints to better meet both clinical and payer needs.”
